TY - JOUR
T1 - Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection
AU - Rubin, Mark N.
AU - Shah, Ruchir
AU - Devlin, Thomas
AU - Youn, Teddy S.
AU - Waters, Michael F.
AU - Volpi, John J.
AU - Stayman, Aaron
AU - Douville, Colleen M.
AU - Lowenkopf, Ted
AU - Tsivgoulis, Georgios
AU - Alexandrov, Andrei V.
N1 - Funding Information:
This work was funded by NeuraSignal, Inc.
Publisher Copyright:
© 2023 The Authors. Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc.
PY - 2023/11/1
Y1 - 2023/11/1
N2 - BACKGROUND: Right to left shunt (RLS), including patent foramen ovale, is a recognized risk factor for stroke. RLS/patent foramen ovale diagnosis is made by transthoracic echocardiography (TTE), which is insensitive, transesophageal echocardiography, which is invasive, and transcranial Doppler (TCD), which is noninvasive and accurate but scarce.METHODS: We conducted a prospective, single-arm device clinical trial of robot-assisted TCD (raTCD) versus TTE for RLS diagnosis at 6 clinical sites in patients who presented with an event suspicious for embolic cerebrovascular ischemia from October 6, 2020 to October 20, 2021. raTCD was performed with standard TCD bubble study technique. TTE bubble study was performed per local standards. The primary outcome was rate of RLS detection by raTCD versus TTE.RESULTS: A total of 154 patients were enrolled, 129 evaluable (intent to scan) and 121 subjects had complete data per protocol. In the intent to scan cohort, mean age was 60±15 years, 47% were women, and all qualifying events were diagnosed as ischemic stroke or transient ischemic attack. raTCD was positive for RLS in 82 subjects (64%) and TTE was positive in 26 (20%; absolute difference 43.4% [95% CI, 35.2%-52.0%];
P<0.001). On prespecified secondary analysis, large RLS was detected by raTCD in 35 subjects (27%) versus 13 (10%) by TTE (absolute difference 17.0% [95% CI, 11.5%-24.5%];
P<0.001). There were no serious adverse events.
CONCLUSIONS: raTCD was safe and ≈3 times more likely to diagnose RLS than TTE. TTE completely missed or underdiagnosed two thirds of large shunts diagnosed by raTCD. The raTCD device, used by health professionals with no prior TCD training, may allow providers to achieve the known sensitivity of TCD for RLS and patent foramen ovale detection without the need for an experienced operator to perform the test. Pending confirmatory studies, TCD appears to be the superior screen for RLS compared with TTE (funded by NeuraSignal).REGISTRATION: URL: https://www.CLINICALTRIALS: gov; Unique identifier: NCT04604015.
AB - BACKGROUND: Right to left shunt (RLS), including patent foramen ovale, is a recognized risk factor for stroke. RLS/patent foramen ovale diagnosis is made by transthoracic echocardiography (TTE), which is insensitive, transesophageal echocardiography, which is invasive, and transcranial Doppler (TCD), which is noninvasive and accurate but scarce.METHODS: We conducted a prospective, single-arm device clinical trial of robot-assisted TCD (raTCD) versus TTE for RLS diagnosis at 6 clinical sites in patients who presented with an event suspicious for embolic cerebrovascular ischemia from October 6, 2020 to October 20, 2021. raTCD was performed with standard TCD bubble study technique. TTE bubble study was performed per local standards. The primary outcome was rate of RLS detection by raTCD versus TTE.RESULTS: A total of 154 patients were enrolled, 129 evaluable (intent to scan) and 121 subjects had complete data per protocol. In the intent to scan cohort, mean age was 60±15 years, 47% were women, and all qualifying events were diagnosed as ischemic stroke or transient ischemic attack. raTCD was positive for RLS in 82 subjects (64%) and TTE was positive in 26 (20%; absolute difference 43.4% [95% CI, 35.2%-52.0%];
P<0.001). On prespecified secondary analysis, large RLS was detected by raTCD in 35 subjects (27%) versus 13 (10%) by TTE (absolute difference 17.0% [95% CI, 11.5%-24.5%];
P<0.001). There were no serious adverse events.
CONCLUSIONS: raTCD was safe and ≈3 times more likely to diagnose RLS than TTE. TTE completely missed or underdiagnosed two thirds of large shunts diagnosed by raTCD. The raTCD device, used by health professionals with no prior TCD training, may allow providers to achieve the known sensitivity of TCD for RLS and patent foramen ovale detection without the need for an experienced operator to perform the test. Pending confirmatory studies, TCD appears to be the superior screen for RLS compared with TTE (funded by NeuraSignal).REGISTRATION: URL: https://www.CLINICALTRIALS: gov; Unique identifier: NCT04604015.
KW - echocardiography
KW - embolic stroke
KW - embolism
KW - ischemic stroke
KW - patent foramen ovale
KW - robotics
KW - ultrasound
KW - Echocardiography
KW - Echocardiography, Transesophageal
KW - Prospective Studies
KW - Humans
KW - Middle Aged
KW - Male
KW - Stroke/etiology
KW - Robotics
KW - Ultrasonography, Doppler, Transcranial
KW - Female
KW - Aged
KW - Foramen Ovale, Patent/complications
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U2 - 10.1161/STROKEAHA.123.043380
DO - 10.1161/STROKEAHA.123.043380
M3 - Article
C2 - 37795589
AN - SCOPUS:85175585492
SN - 0039-2499
VL - 54
SP - 2842
EP - 2850
JO - Stroke
JF - Stroke
IS - 11
ER -